Computed Tomography X-ray System recallZ-2704-2020 · Shanghai United Imaging Healthcare Co., Ltd. · initiated Jun 20, 2020
Class II Open, Classified All recalls posted in July 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Shanghai United Imaging Healthcare Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
FDA root cause category: Device Design
What the company is doing
A Customer Notification Letter was sent to the affected consignees on 06/20/2020 via email. United Imaging will replace the mylar strip with an improved one on the affected products via on-site update. On 8/30/2024, a correction notice was sent identifying an additional serial number.
Recall details
- Recall number
- Z-2704-2020
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jun 20, 2020
- Posted by the FDA
- Jul 27, 2020
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 4
- Product code
- JAK
- FDA submissions
- K181414
- Distribution
- US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
Product description
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
Code information (models, lots, serial numbers)
SN 300162, 300163, 300174, 300176
Other devices under the same FDA submission
1 device cleared under K181414 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- uCT uCT 530Shanghai United Imaging Healthcare Co., Ltd. · System, X-Ray, Tomography, Computed3 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 85868).
- Z-2703-2020 · Open, ClassifiedComputed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstr…
- Z-2705-2020 · Open, ClassifiedComputed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstr…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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